Ascendis Pharma

Ascendis Pharma A/S is a biopharmaceutical company, which engages in the development of drug candidates. It specializes on its TransCon technologies to create prodrugs that provide for the predictable and sustained release of an unmodified parent drug. The company was founded by Jan Moller Mikkelsen, Dirk Vetter, and Harald Rau in September 2006 and is headquartered in Hellerup, Denmark.

Earnings data Q1 2021

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Earnings data Q4 2024

Ascendis Pharma reports strong revenue growth and market potential

Ascendis Pharma's financial performance in Q4 2022 showed revenue growth but operating losses, with a strong cash position.
Strengths lie in the TransCon technology platform, differentiation of products, and established commercial infrastructure.
Challenges include monitoring requirements, launch strategy comparisons, and market access strategies.
Opportunities arise from potential approvals, market dynamics, and clinical benefits of product candidates.

Ascendis Pharma reports robust Q1 revenue, faces regulatory challenges

Ascendis Pharma delivered a strong financial performance in Q1 2023, driven by revenue growth and strategic initiatives.
The company faces regulatory challenges and market dynamics that require resolution and strategic planning for sustained growth.
Opportunities for market expansion and product development exist through leveraging success factors and addressing regulatory hurdles.
Investor interest in Ascendis Pharma's future prospects is evident through analyst inquiries on growth expectations and market strategies.

Ascendis Pharma reports robust Q2 earnings amidst market challenges

Ascendis Pharma's Q2 performance reflects strong revenue generation and strategic advancements in key product pipelines, positioning the company for future growth.
Despite challenges in market shortages and regulatory processes, Ascendis Pharma's focus on innovation and market differentiation presents opportunities for expansion.
The company's emphasis on TransCon technology's unique benefits and market positioning underscores its competitive strength and growth potential in rare disease therapeutics.

Ascendis Pharma reports strong Q3 revenue growth and pipeline progress

Ascendis Pharma's Q3 2023 performance reflects revenue growth driven by SKYTROFA and progress in key pipeline programs.
The company's strategic focus on innovative therapies and patient-centric approaches positions it for future growth and market leadership.
While facing challenges like supply chain disruptions and market competition, Ascendis Pharma has opportunities for expansion and therapeutic innovation.
Balancing financial performance with pipeline advancement and commercial optimization will be crucial for Ascendis Pharma's sustainable success.

Ascendis Pharma excels in revenue growth and market leadership

Ascendis Pharma's strong performance in 2023, driven by SKYTROFA and TransCon PTH, positions the company for continued growth and success.
Despite challenges in market competition and treatment complexities, the company's strategic focus on patient outcomes and revenue growth is evident.
Opportunities in expanding therapeutic areas and maintaining market share stability offer potential for Ascendis Pharma's long-term success and value creation.

Ascendis Pharma reports robust Q1 performance and eyes global expansion

Ascendis Pharma's Q1 2024 performance reflects strong revenue growth, improved operational efficiency, and successful product launches, positioning the company for sustainable growth.
While facing challenges in market competition and financial targets, Ascendis Pharma's strategic strengths in product development and market expansion present growth opportunities.
The company's focus on innovation, commercial execution, and market positioning underscores its potential to become a leader in growth disorders and metabolic diseases.
Investors should monitor Ascendis Pharma's progress in achieving cash flow breakeven, expanding product portfolios, and navigating regulatory landscapes for future growth potential.

Ascendis Pharma excels in Q2 with YORVIPATH approval and revenue growth

Ascendis Pharma's Q2 2024 earnings call highlighted strong financial performance, successful product approvals, and strategic commercialization efforts.
The company faces challenges in pricing strategies, market dynamics, and ensuring patient uptake, but opportunities exist in expanding market reach and advancing pipeline programs.
Overall, Ascendis Pharma's focus on innovation, patient support, and financial growth positions it well for continued success and market leadership in the biopharmaceutical industry.

Ascendis Pharma reports robust Q3 performance and eyes strategic growth

Ascendis Pharma showcased strong performance across its product portfolio and pipeline candidates, with notable revenue growth and promising clinical outcomes.
While facing challenges in market penetration and regulatory processes, the company is well-positioned to capitalize on growth opportunities through strategic collaborations and upcoming product launches.
By navigating challenges effectively and leveraging opportunities, Ascendis Pharma aims to drive sustainable growth and value creation in the pharmaceutical market.

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Ascendis Pharma stock zoomed higher Monday — closing in on a breakout — after the FDA signed off on its embattled thyroid disease drug.

Ascendis Pharma Zips Higher After FDA Approves Embattled Thyroid Drug

The stock of Ascendis Pharma A/S jumped 11% early Monday, after the biotech said the U.S. Food and Drug Administration has approved its Yorvipath as the first and only treatment for a rare endocrine disease.

Ascendis Pharma's stock surges after FDA approval for first and only treatment for rare disease

The U.S. Food & Drug Administration has approved Ascendis Pharma's therapy to treat adult patients with a hormone disorder, bringing an end to its years-long efforts to introduce the treatment to the market, the company said on Monday.

FDA approves Ascendis Pharma's hormone disorder therapy

ASND's pipeline includes promising candidates for various endocrine disorders and oncology, positioning the company as a leader in innovative medical solutions. FDA-approved Skytrofa for pediatric GHD showcases TransCon technology's efficacy in enhancing patient outcomes. The company's financial outlook is strong, with projected revenue growth and positive EBIT expected by 2025.

Weaker USD, Revenue Growth, And TransCon Technology Make Ascendis Pharma A Strong Buy Opportunity

• Data demonstrate significant improvements in well-being and physical functioning compared to placebo in patients treated for 1 year with TransCon CNP at the pivotal 100μg/kg/week dose

Data from Phase 2 ACcomplisH Trial of TransCon CNP in Children with Achondroplasia Presented at ICCHBH 2024

COPENHAGEN, Denmark, June 04, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that company executives will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024, at 8:00 a.m. ET in Miami, Florida.

Ascendis Pharma to Participate in the Goldman Sachs 45th Annual Global Healthcare Conference

-  40% of efficacy-evaluable patients (2 out of 5) in the initial cohort of patients with anti-PD-1 refractory melanoma treated with TransCon IL-2 β/γ  in combination with TransCon TLR7/8 Agonist exhibited confirmed clinical responses with no new safety signals

Ascendis Pharma Presents New Data and Updated Results from Phase 1/2 IL-Believe Trial at ASCO 2024

COPENHAGEN, Denmark, May 30, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that it will host informational booths, events, and presentations showcasing use of its innovative TransCon technology in the areas of growth hormone deficiency (GHD), hypoparathyroidism, achondroplasia, and Turner syndrome during ENDO 2024, the annual meeting of the Endocrine Society being held June 1-4, 2024, in Boston.

Ascendis to Spotlight Latest Updates for TransCon™ Rare Endocrinology Disease Portfolio at ENDO 2024

Per the FDA, the data submitted by Ascendis (ASND) for its hormone replacement therapy constitutes a major amendment to its previously-submitted data. A final decision is expected by Aug 14.

FDA Delays Decision on Ascendis' (ASND) Hormone Therapy Filing

The U.S. Food & Drug Administration has extended its review of Ascendis Pharma's therapy to treat adult patients with a hormone disorder, the company said on Tuesday.

FDA extends review of Ascendis Pharma's hormone disorder therapy

- Prescription Drug User Fee Act (PDUFA) goal date extended by three months for further review of submission to August 14, 2024

Ascendis Pharma Announces Extension of U.S. Food and Drug Administration Review Period for TransCon™ PTH for Adults with Hypoparathyroidism

COPENHAGEN, Denmark, May 13, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced 2-year results from a post-hoc analysis of the Company's Phase 3 PaTHway Trial demonstrating significant and sustained improvements in renal function in adults with chronic hypoparathyroidism treated with TransCon PTH (palopegteriparatide). The data were shared in an oral presentation on May 12 by Peter Schwarz, M.D., Professor of Clinical Medicine at the University of Copenhagen, during the European Congress of Endocrinology 2024 (ECE 2024), the annual meeting of the European Society of Endocrinology.

Significant and Sustained Improvements in Renal Function Reported for Adults with Chronic Hypoparathyroidism Treated with TransCon™ PTH (Palopegteriparatide): 2-year Results from Phase 3 PaTHway Trial

COPENHAGEN, Denmark, May 09, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that new TransCon PTH (palopegteriparatide) data supporting clinical and quality-of-life benefits in adult patients with chronic hypoparathyroidism will be presented at the European Congress of Endocrinology being held May 11-14, 2024, in Stockholm.

Latest Clinical and Quality-of-Life Data for TransCon™ PTH (Palopegteriparatide)-Treated Adults with Chronic Hypoparathyroidism to Be Presented at ECE 2024

Ascendis Pharma is expected to achieve cash flow break even by the end of 2024, driven by its core franchise of medicines for rare endocrinology conditions. The company's approved drug, Skytrofa, has shown strong sales and has the potential to be a blockbuster. Ascendis Pharma's TransCon PTH, a parathyroid hormone replacement therapy, is awaiting FDA approval and has the potential to capture a significant market share in the treatment of hypoparathyroidism.

An Update On Ascendis Pharma's Path To Profitability

Ascendis Pharma A/S (ASND) Q1 2024 Earnings Conference Call May 2, 2024 4:30 PM ET Company Participants Tim Lee - Senior Director, Investor Relations Jan Mikkelsen - President & Chief Executive Officer Scott Smith - Executive Vice President & Chief Financial Officer Stina Singel - Executive Vice President, Clinical Development, Oncology Joe Kelly - US General Manager Conference Call Participants Jessica Fye - JPMorgan David Lebowitz - Citi Li Watsek - Cantor Joseph Schwartz - Leerink Partners Gavin Clark-Gartner - Evercore ISI Kelly Shi - Jefferies Derek Archila - Wells Fargo Paul Choi - Goldman Sachs Vikram Purohit - Morgan Stanley Leland Gershell - Oppenheimer Sushila Hernandez - Kempen Operator Good day, and welcome to the Q1 2024 Ascendis Pharma Earnings Conference Call. At this time, all participants are in a listen-only mode.

Ascendis Pharma A/S (ASND) Q1 2024 Earnings Call Transcript

— Rollout of YORVIPATH ® initiated in Germany and Austria, with an estimated 55 doctors writing prescriptions and ~100 patients receiving commercial product as of March 31

Ascendis Pharma Reports First Quarter 2024 Financial Results

COPENHAGEN, Denmark, April 25, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it will report first quarter 2024 financial results and provide a business update on Thursday, May 2, 2024, after the close of the U.S. financial markets. Ascendis Pharma will also host a conference call and live webcast on May 2, 2024, at 4:30 p.m. Eastern Time (ET) to discuss its first quarter 2024 financial results.

Ascendis Pharma to Report First Quarter 2024 Financial Results and Provide Business Update on May 2, 2024

Ascendis Pharma (ASND) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.

Why Earnings Season Could Be Great for Ascendis Pharma (ASND)

COPENHAGEN, Denmark, April 24, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the United Kingdom's Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for YORVIPATH® (palopegteriparatide; developed as TransCon™ PTH) in Great Britain as a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, and has also granted YORVIPATH orphan drug status. YORVIPATH is a prodrug of parathyroid hormone (PTH 1-34) administered once daily.

United Kingdom's MHRA Approves YORVIPATH® (palopegteriparatide) in Great Britain for the Treatment of Adults with Chronic Hypoparathyroidism

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COPENHAGEN, Denmark, March 04, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that company executives will participate in a fireside chat at the Leerink Partners Global Biopharma Conference 2024 on Monday, March 11, 2024 at 2:00 p.m. ET in Miami, Florida.

Ascendis Pharma to Participate in the Leerink Partners Global Biopharma Conference 2024

Does Ascendis Pharma A/S (ASND) have what it takes to be a top stock pick for momentum investors? Let's find out.

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